Thermo Fisher Scientific seeks a Quality Operations Supervisor to lead GMP-compliant QA operations on rotating 12-hour shifts. The role involves supervising document review processes, resolving quality issues, managing team performance, and maintaining regulatory compliance across 24/7 manufacturing operations.
Responsibilities
- Oversee document review processes and ensure timely batch release
- Identify and resolve significant quality issues through cross-functional coordination
- Review and approve deviations, out-of-specification reports, CAPAs, and batch records
- Lead quality continuous improvement initiatives and process optimization projects
- Prepare quality data for internal and external stakeholder meetings and audits
Requirements
- Experience in quality assurance or quality operations supervision in regulated manufacturing
- Knowledge of Good Manufacturing Practices (GMP) and regulatory compliance requirements
- Proven ability to manage teams and conduct performance evaluations
- Strong documentation and data integrity practices in regulated environments
- Experience with quality systems, deviations, CAPAs, and batch record review
- Ability to work flexible 12-hour shifts including nights
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